Biopharma Warns about Upholding Regulatory Standards of Quality

Seven months into the pandemic, the innovative biopharmaceutical industry continues to step up work on researching and testing therapeutics that could lower mortality rates or lessen the severity of COVID-19. Over recent months, the results of rigorous clinical trials of repurposed medicines to achieve quick wins have been mixed, while the pipeline for new treatments does hold promise. Considerable efforts are going into planning to scale up and share manufacturing capacity should treatments prove safe and effective.

IFPMA is strongly committed to rigorous regulatory standards for approval of COVID-19 treatments and vaccines. No matter how urgently action is needed against the coronavirus public health emergency, it is imperative that the highest standards of quality, safety and efficacy are upheld everywhere. IFPMA member companies are fully committed to transparency in reporting clinical trial results whether these are good or bad; they support the need to inform the public of what they know, as well as what they don’t know about the vaccines in development.

The innovative biopharmaceutical industry believes that ensuring the right level of engagement with society whilst assessing and approving vaccines will be key to gaining the public’s trust in COVID-19 vaccines and helping end the coronavirus pandemic.

Vaccines may ultimately bring an end to the pandemic, but there is an urgent need for therapeutic innovation that can offer clinical benefits to COVID-19 patients. Today, more than 300 COVID-19 treatments are being researched or are in clinical trials around the world: some repurposed medicines proven to work against other deadly diseases, others as novel as the virus itself.

Today, 22 leading IFPMA member companies are involved in R&D for therapeutics and together have enacted or are conducting 81 clinical trials evaluating therapeutics’ effectiveness. The main COVID-19 treatments being looked at are antivirals, antibodies and convalescent plasma, as well as anti-inflammatories. This is encouraging as the clinical response to help patients with COVID-19 requires multiple treatment options but there is no magic bullet to treat or cure patients with the virus.

For some repurposed treatments, hopes have been dashed. Rigorous clinical trials have shown that hydroxychloroquine for patients with mild COVID-19 does not work. Tocilizumab has also proven to show no marked improvement in adult patients with severe COVID-19-associated pneumonia. In contrast, dexamethasone has proven effective in seriously ill COVID-19 patients. Researchers are now waiting for results of repurposed treatments used in combination.

Elsewhere, hopes have been fulfilled: remdesivir has gone in a matter of months from an investigational compound to an available therapy that shortens recovery times among hospitalized patients. Further down the line, other novel treatments may help patients with weakened immune systems. Progress is being made, but at a slower pace than society would have hoped for. Should a treatment prove safe or effective, biopharmaceutical companies are already planning upfront how to scale up and be ready to share manufacturing capacity in order to meet potential demand.

“We’re continuing to see extraordinary collaboration across the biopharmaceutical industry, academia and biotech to accelerate R&D and develop new treatments and vaccines at record speed,” said David A. Ricks, chairman and CEO of Eli Lilly and Company and president of IFPMA. “Working together, we’ve made significant progress in the search for new treatments and vaccines to contain and ultimately extinguish COVID-19. And to ensure that no one is left behind in the face of this devastating disease, our industry remains committed to making sure they are available and affordable for all patients who need them”.

Thomas Cueni, Director General of IFPMA, commented on progress in finding treatments for COVID-19: “We’re still on a learning curve. However, we remain on course with single-minded focus and a willingness to take on the risks inherent in all innovation while pulling together our R&D capabilities for the benefit of patients living up to our commitments. What we’ve learnt so far is that there will unlikely be a magic bullet for everyone against COVID-19, but that is no excuse for cutting corners in our haste to approve new treatments or vaccines.”

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